MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37603 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 07/21/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead.(b)(4).
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Event Description
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A consumer reported that a poor communication screen was displayed on the patient programmer and the patient was getting poor communication.The patient was recently implanted and bandages and some swelling was present.On the day of this report, the patient met with a nurse for their health care provider and they turned down settings a little bit.Since the settings were turned down, the patient's hand was shaking really bad and the shaking was terrible.The shaking had started the day prior to this report and had gone away, but it was back today.The patient only had shaking in their hand and it was gradually getting worse.On 2015 (b)(6), the patient had cramping in their leg.The patient's indication for use is essential tremor and movement disorders.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information received from a consumer reported the patient had contacted their health care provider (hcp) about the shaking and leg cramping.The patient had an appointment scheduled for 2015 (b)(6).The patient's daughter was able to turn stimulation up and down for the patient, but they could not seem to get it in the right spot.The resolve the patient's shaking, they had been taking more medication and they had turned stimulation up.The patient was working with their hcp for their leg.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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